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Job Description
A wonderful opportunity has arisen to join the Ballydine site as Associate Director Quality Assurance. Reporting to the Quality Director, the incumbent will work with the Quality Leadership team to ensure compliance with all regulatory requirements for Drug Substance (DS), Spray Dried Intermediate (SDI) and Drug product (DP) released to downstream customer. This is a permanent role with opportunities for some home working.
Role Responsibilities
Qualification Requirements
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
N/A
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
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Job Description
Support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
This position is responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, vendors and Country Offices. This role is accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures, policies, and all applicable worldwide regulations and guidelines.
Primary activities include, but are not limited to:
Main requirements:
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
Shift:
1st - DayValid Driving License:
YesHazardous Material(s):
n/aOfficial account of Jobstore.
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Associate Director of Quality Systems ensures that the GMP systems and controls in place at the site meet Global Quality Standards and applicable regulatory requirements. S/he liaises with Global Quality leadership and is a conduit for driving harmonization and alignment within the biologics network. Additionally responsible for ensuring that significant quality concerns are documented within the Quality Management System (QMS) and for maintaining systems that prompt the appropriate mitigation/remediation actions.
This position typically has oversight of direct reports and will assign resources and priorities, ensure adequate training, coaches and develops staff, evaluates performance, and supports overflow of tasks across Quality as needed. The Director of Quality Systems is a member of the Senior Quality organization and participates in decision making for escalations and communication of decisions at the site.
Key Responsibilities:
Key Qualifications:
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is committed to enhancing Australia's biotech landscape through a long-term partnership, focusing on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility is set to be a key player in Australia's response to future health threats. This collaboration emphasizes not only cutting-edge medical technology but also job creation and local talent development. We invite visionary professionals to join us on this transformative journey and make a tangible impact on global health security.
Moderna is seeking an Associate Director for Quality Control at our new manufacturing site in Melbourne, Australia. This role involves overseeing commercial testing functions in the Quality Control department, supporting raw materials and drug substances testing, including microbiological and environmental monitoring tests. The role includes managing laboratory personnel and acting as an interdepartmental liaison, contributing significantly to our quality control and assurance operations.
Here's What You’ll Do:
Within 3 Months, You Will…
Oversee the day-to-day operations of the Quality Control commercial program testing functions, including stability testing.
Ensure timely delivery of test results and provide efficient support for deviations.
Start implementing Lean methodologies to enhance efficiency in the QC processes.
Within 6 Months, You Will…
Manage laboratory personnel, focusing on performance management, mentoring, and career development.
Assist in the development of Standard Operating Procedures and laboratory data systems to ensure cGMP compliance.
Support laboratory investigations, change controls, and CAPAs related to QC operations.
Within 12 Months, You Will:
Contribute to budget planning and resource allocation for the Quality Control department.
Provide essential testing data and quality-related information to support product studies and stability programs.
Collaborate with other departments, such as AS&T, Quality Assurance, and Regulatory Affairs, for method transfer and qualification activities.
Here’s What You’ll Bring to the Table:
Minimum education required: Bachelor’s Degree in a relevant scientific discipline.
Minimum experience required: 10 + years in applied industry experience; 4-6 years of management/supervisory experience.
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs.
Previous supervisory experience is preferred, including testing scheduling and lab project management.
Minimum knowledge required: general laboratory operations, method acquisition, qualification.
Minimum skills required:
Technical writing.
Proficiency with Microsoft Office Programs.
Familiarity with electronic databases (e.g., LIMS, SAP, LMS).
Familiarity with QC operations including bioassay, chemistry, and microbiology.
HPLC Instrumentation/ Software experience is preferred.
Strong written and oral communication skills as well as organizational skills.
Knowledge of industry standards and guidelines, experience supporting compliance audits.
Demonstrated ability to work effectively under established guidelines and instructions.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be tasked with the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.
Primary Duties:
Operational Quality Management:
Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).
Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).
Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.
In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
Inspection Preparation and Management:
Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
Lead and support GCP inspections, worldwide. The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
Contribute to the development and/ or revision of our Company policies, SOPs and training materials.
Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.
Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.
Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
CAPA Management Support:
Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Track all inspection CAPA and regulatory commitments and checks evidence of completion.
Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.
Other activities:
Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
Education:
Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.
Experience:
Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
Experience with delivering effective CAPA management solutions.
Experience with risk management tools and processes within the clinical quality framework.
Skills:
Superior oral and written communication skills in an international environment.
Ability to manage and develop others, including formal performance management when required.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Lead cross-functional teams of business professionals within and outside our Research Division.
Act urgently for worldwide health authority inspection matters.
Analyze, interpret and solve complex problems.
Think strategically and objectively and with creativity and innovation.
Effectively interact with all levels of specialists & management and exert influence to achieve results.
Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
#EligibleforERP
MRLGCTO
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
Click here to request this role’s pay range.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$135,500.00 - $213,400.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
General Summary:
The Senior Director, Quality GLP, Biomarkers and Research has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance
Key Duties and Responsibilities:
• Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
• Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
• Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
• Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner
• Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
• Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
• Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
• Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
• Chairs relevant operational governance meetings (e.g. QLT)
• Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TRPM to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
• Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
• Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
• Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
• Provides strategic direction, oversight, coaching and mentoring to direct reports.
Education and Experience:
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
POSITION SUMMARY:
The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software-as-a-Service (SaaS) solutions. This role ensures risk-based, overall integrity of electronic data across all stages of data life cycle and leads development and refinement of quality management systems standards and policies to align with various GxP regulations.
RESPONSIBILITIES:
The responsibilities of this position will include, but are not limited to, the following:
Key Technical Knowledge, Skills and Competencies:
Education and Experience:
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
GENERAL POSITION SUMMARY
The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for microbial control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.). This individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and provide technical support for the overall contamination strategy and facility monitoring programs.
The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs. In addition, the successful candidate will be experienced in the fields of aseptic process technologies, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems.
This role will report to the Director of Quality Validation and Engineering within the Vertex Cell and Genetics Therapies QA group.
KEY DUTIES AND RESPONSIBILITIES
Sterility Assurance and Aseptic Controls
Operations – Facilities, Validation, and Engineering Support
Audit / Inspection Support
Deployment of QMS and Establishment of Compliance Expectations
REQUIRED EDUCATION AND EXPERIENCE
#LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
Calling all passionate quality leaders! Join us as Associate Director & Qualified Person and make a significant impact on the success of our global clinical supply chain!
This pivotal role lets you build and lead a team, ensuring the flawless delivery of life-changing medicines worldwide.
Join us and make a real difference in patient lives.
Purpose of the position
In this crucial role, you'll directly support the Director, GDQ (Global Development Quality), by ensuring the smooth operation of our global clinical supply chain. You'll achieve this by overseeing all activities related to the disposition of clinical finished goods used in our worldwide trials. This includes building a dedicated team of two Senior QA Specialists at our Haarlem site.
Your primary focus will be ensuring the quality and compliance of investigational medicinal products (IMPs) throughout our Global Clinical Supply (GCS) Warehouse and Distribution network. You'll achieve this by overseeing all quality assurance activities related to Good Manufacturing Practice (GMP) compliance for the IMP license. Additionally, you'll design and manage a robust Quality Management System (QMS) for the clinical supply warehouse and distribution functions.
To maintain a seamless global clinical supply chain, you'll manage the distribution, and final disposition of clinical finished goods. This collaborative role will require you to work closely with internal and external partners to guarantee the on-time delivery of cGMP-compliant clinical supplies worldwide. You'll also be the company's voice during regulatory inspections pertaining to the IMP license and QMS.
Welcome to our team
The Global Development Quality (GDQ) organization is responsible for providing quality oversight of internal clinical packaging and distribution operations and supply chain management support for the end-to-end clinical supply chain.
Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.
Primary responsibilities
Act as Quality site lead / QP for quality aspects of warehousing and distribution activities at the site in Haarlem.
Provide QP certification of batches of IMPs packaged for Clinical Trial use as required by directive 2001/20/EC.
Drive the implementation of the quality strategy at site.
Oversee the recruitment, management and development of the Quality team.
Lead the departmental and site preparation for internal and external audits
Champion the continuous improvement of the quality strategy by prioritizing, initiating and monitoring related improvements.
Legally responsible for the executions of releases and the execution of potential recalls.
Your profile
Master's degree in science or Pharmacy qualification (QP eligible).
6-8 years in pharma Quality Assurance, ideally with manufacturing & logistics experience.
Several years of experience as a Qualified Person (QP).
Strong team leadership & coaching skills.
Proven ability to analyze, recommend & lead quality initiatives.
Excellent communication with strong analytical thinking and EU GMP/cGMP knowledge.
Fluency in English (written & spoken)
Travel willingness (up to 10%)
What we offer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
Competitive salary and a 3% year-end bonus;
35,5 days of leave;
Attractive collective health care insurance package with considerable reduction rates;
Solid Pension Plan;
Incentive Plan;
Travel allowance for commuting;
On-site sports facilities
Numerous training, coaching and e-learning modules for long term job opportunities and development
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
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Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The Director, Quality Risk Management will report to the Quality and EHS Risk Monitoring and Review Lead, within the Quality Systems and Operations Compliance (QSOC) group.
Role is responsible to define the global strategy, development, implementation and maintenance of the PGS Quality Risk Management business process in accordance with industry expectations and regulatory requirements. The role will accomplish this by defining harmonized and standardized practices targeted at anticipating and avoiding unacceptable risks, aligning risk categories and methodologies for communication and fostering an informed culture whereby proactive behaviors and motivations are championed. In addition, the role will be responsible for the continuous improvement of the current Quality Risk Review process to ensure integration with both the Quality and EHS risk review and monitoring processes allowing for harmonized risk prioritization methodology and risk prioritization rules.
Role is responsible for leading cross-functional activities and teams that sustain, control, and improve the QRM processes within their remit. Additionally, the role will provide expertise in the collation, analysis, visualization, and presentation of risk information to enable customers to understand and apply QRM principles through knowledge transfer. This will involve the development of a business case for a longer-term digital strategy to manage all risk data.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
Strong contributor to the design and development of the strategy for the global deployment of a Proactive Quality Risk Management program including governance, communication, infrastructure requirements, deployment timeline, tool application, monitoring.
Contributes innovative ideas for continuous improvement.
Collaborates and communicates at all levels to ensure local and global processes are well defined and opportunities for continual improvement are explored.
Maintains the group’s standards and supporting documents in support of current Regulatory requirements (ISO, ICH) and industry expectations for Quality Risk Management.
Leads and/or participates in risk reviews with the business leaders, Supports the aggregation, analysis, and interpretation of data from multiple internal and external sources; and reports patterns, insights, and trends into business performance, facilitate decision making and identify opportunities for improvement.
Risk expert who strategizes and creates new risk methodologies or customized risk tools for the quality management system as well as business/operational needs (e.g.: Contam Ctrl, risk profile, new facility design).
Develop and execute a training strategy that is flexible based on the needs of the organization.
May support the design and development of training materials (or facilitates service providers) in support of risk tools such as Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP) and other customized risk tools. Provides training on these tools either remotely, in person or through the creation of e-learning modules.
Leads the global Risk Community of Practice with the network focal points (Risk Champions) to share knowledge and best practices.
Facilitates critical, complex risk assessments, as needed.
Partner with digital on future electronic solutions to support and manage QRM activities and data.
Collaborates with the Business line Leadership as well as with partners outside of Quality for topics impacting our mission.
Lead or actively drive integration of risk principles on transversal projects, as assigned.
Support the development and generation of performance indicators to measure progress of implementation and effectiveness use of the QRM.
Bachelor’s degree in Engineering or science discipline or equivalent.
10+ years of quality assurance and/or business process experience in the medical device, biotech and/or pharmaceutical industry.
Quality Risk Management and/or medical device risk management experience.
Strong understanding and practical use of ICH, ISO, and cGMP regulations.
Recent experience demonstrating the capability to strategize, collaborate and execute on the successful completion of process improvements at a global level.
Strong collaboration and conflict management skills when working transversally across multiple Business Units to achieve global objectives.
High level of energy and enthusiasm and ability to energize others.
Proven critical thinking skills to be able to connect GxP requirements with business processes.
Effective verbal and written communication skills, including presentation skills. Able to communicate effectively at all levels of a matrix organization, as well as teach and present new ideas with clarity and simplicity.
Ability to influence Pfizer policies/positions in response to a changing regulatory landscape.
Master’s degree or equivalent.
Experience with the use of risk management tools (FMEA, HACCP, process mapping, and root cause analysis tools).
Knowledge of digital systems to manage data and reporting, experience using data to drive solutions to business challenges.
A willingness to contribute within a learning environment by sharing knowledge and best practices across the organization.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
10-20% travel when required.
Work Location Assignment: Flexible.
Last day to apply: March 22, 2024.
Relocation assistance: No.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Job Description
General Summary:
The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.
**In this a 2nd, shift, On-Site designated role. ou will work five days per week on-site with ad hoc flexibility.**
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
On-Site Roles
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
#LI-Onsite #LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you.
CLA is dedicated to building a culture that invites different beliefs and perspectives to the table, so we can truly know and help our clients, communities, and each other.
Our Perks:
Flexible PTO (designed to offer flexible time away for you!)
Up to 12 weeks paid parental leave
Paid Volunteer Time Off
Mental health coverage
Quarterly Wellness stipend
Fertility benefits
Complete list of benefits here
CliftonLarsonAllen, LLP is hiring an Assurance Director or Manager to support our Nonprofit practice, in Massachusetts. Office locations include: Boston, Quincy, Lexington, Andover, and Worcester.
How you’ll create opportunities in this Assurance Manager or Director role:
Manage and develop relationships with great clients.
Assist clients in obtaining necessary funding to continue to positively impact their community.
Assist clients with meeting their audit and financial planning objectives by using a range of tools.
Be creative with staff development, mentoring, and overseeing client engagement teams.
Lead the engagement progress by monitoring time budgets and deadlines for adherence.
Communicate important developments to the engagement principal along with facts, conclusions, and recommendations.
What you will need:
You have a Bachelor's Degree in Accounting, Finance, or a related field.
You have a minimum of 6 years of public accounting experience with emphasis in financial statement preparation and audits.
CPA license certification is required.
You jump at the chance to help others and you’re ready to lead a team of high-performing people.
You have a knack for solving issues and can confidently bring solutions to the table.
You love to work with clients’ to help their businesses succeed strategically.
#LI-BV1
Equal Opportunity Employer /AA Employer/Minorities/Women/Protected Veterans/Individuals with Disabilities.
Click here to learn about your hiring rights.
Wellness at CLA
To support our CLA family members, we focus on their physical, financial, social, and emotional well-being and offer comprehensive benefit options that include health, dental, vision, 401k and much more.
To view a complete list of benefits click here.
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(The role is only open to candidates based in Poland)
Job Overview
This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions
• Contributes to the development, and supports implementation of the Quality Management Plan within the scope of the assignment this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness in project delivery.;
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.
• Works in close cooperation with teams to manage non-compliance, quality issues
• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.
• Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs.
• Acts as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.;
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.
Qualifications
• Bachelor's Degree Req
• Typically requires 5-7 years of prior relevant experience.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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Job Summary
The Director, Quality Management provides strategic oversight, leadership and direction to the Quality function and will be accountable for the CHPS (Cardinal Health Packaging Solutions – repackaging & bulk up) business unit within the Cardinal Health Pharmaceutical Segment.
What Quality Management contributes to Cardinal Health
Quality Management is responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications to ensure that products and services are reliable, safe and effective.
Demonstrates knowledge of quality systems and approaches.
Demonstrates an understanding of the relevant regulations, standards and operating procedures.
Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Build and foster One Team Quality Culture.
Responsibilities
Responsible for the release of final product before distribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.
As the head of the Quality Team for CHPS, ensure release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.
Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner.
Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.
Must be able to approve emergency change controls but understanding the nature of the content including intermediate steps and make the link with the final product and any regulatory requirement.
Understands release product issue and evaluate their potential impact on product quality and compliance.
Escalates complex issues to leadership in a timely manner.
Manages professional employees, frontline supervisors and business support staff while maintaining strong relationships with customers.
Prioritizes and ensures work is delivered in an efficient way.
Provides daily problem solving.
Represents Quality in meetings related to his/her area of responsibility internally and externally.
Performs other duties as assigned.
Qualifications
Bachelors and Advanced degree in related field or equivalent work experience, preferred.
10+ years’ experience in Biopharma, Pharmaceutical or Medical Device regulated fields.
At least 7-10 years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device), ISO and/or DEA regulated environments.
Experience with equipment qualification, software validation, test method validation, and/or process validation.
Works well with others and understand how to be successful in a team environment, especially since customer facing.
Detail oriented, organized, able to multi-task, a self-starter and self-motivated.
Proficient in Microsoft Word and Microsoft Excel and possesses strong technical writing skills.
What is expected of you and others at this level
Provides leadership to managers, experienced quality professionals and manage front line supervisors
Manages an organizational budget
Develops and implements policies and procedures to achieve organizational goals
Assists in the development of functional strategy
Decisions have an extended impact on work processes, outcomes, and customers
Interacts with internal and/or external leaders, including senior management
Persuades others into agreement in sensitive situations while maintaining positive relationships
Anticipated salary range: $112,500 - $181,650
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close: 6/8/2024 *if interested in opportunity, please submit application as soon as possible.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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The roles and responsibilities of a quality assurance varies across different industries. The duties include regulate, arrange and concur on quality procedures, standards and specifications, assess requirements and ensure everything is complied.
The type of jobs related to quality assurance encompass analyst, associate, maintenance technician, audio & video equipment technician, manager of quality assurance, quality assurance assistant manager, quality engineer, quality assurance technician, maintenance manager, safety technician, HVAC technician, consultant, coordinator, director, quality inspector, field service engineer, specialist and supervisor.
The role of quality control is to examine products and materials for defects or deviations from specifications. Responsibilities include monitor operations to ensure that they meet production standards, recommend adjustments to the assembly process, test products being produced, discuss inspection results and report inspection.
The role of quality assurance is to ensure a product or service meets the established standards of quality including reliability, usability and performance required for distribution. Responsibilities include devise sampling procedures, review the implementation of inspection system, document internal audits, investigate customer complaints, compile statistical quality data and analyse data to identify areas of improvement in the quality system.
The role of quality assurance/quality control(QAQC) engineer is to work with quality assurance supervisors, analysing manufacturing processes for improvement using various methods of testing and inspection. Responsibilities include implementing methods for process control, promote quality standards, assist in process certification and review suppliers purchase orders while establishing supplier quality requirements.
The role of QC inspector is to monitor the quality of incoming and outgoing products for a company. Responsibilities include reading blueprints to understand the requirements of products/services, measure product dimensions, recommend improvements to the production process to ensure quality control, document inspection outcomes by completing detailed reports, advise production team about quality control concerns to improve product excellence and supervise the production process.